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临床试验/NCT02886650
NCT02886650已完成不适用

Impact of Thermocoagulation During Invasive EEG Monitoring in Children With Focal Drug-resistant Epilepsies

Fondation Ophtalmologique Adolphe de Rothschild1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Number of children with a decrease of at least 50% of the seizure frequency

研究概览

简要总结

When focal epilepsies become drug-resistant, it could be eligible for cortical surgical resection. Therefore, an invasive EEG monitoring with depth electrodes is often needed during presurgical evaluation. Some of these children can have access to thermocoagulation inside the ictal onset zone, at the end of the monitoring and before to remove the electrodes. These thermocoagulations can disorganize the epileptogenic network thanks to millimetric cortical lesions around the electrodes. The aim is to stop or at least, to reduce the seizure frequency for few weeks or months. This could be a benefit for the child, and also a confirmation of the ictal onset zone and guide the surgeon. This technique is currently used in adult population for years, but remains very rare in children.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Months 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • age 18 month to 17 years old
  • focal drug-resistant epilepsy
  • small size lesion (1 or 2 gyri) or cryptogenic epilepsy
  • indication for EEG monitoring with depth electrodes during presurgical evaluation

排除标准

  • formal contraindication to surgery or anaesthesia
  • functional area or potentially large epileptic area
  • refusal to participate in the study
  • no health insurance coverage

研究组 & 干预措施

Thermocoagulation

Experimental

干预措施: Thermocoagulation (Procedure)

结局指标

主要结局

Number of children with a decrease of at least 50% of the seizure frequency

时间窗: one month after surgery

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

研究点 (1)

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